Status:
COMPLETED
The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects
Lead Sponsor:
Purdue Pharma LP
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg tablets) on the QT/QTc interval.
Eligibility Criteria
Inclusion
- Provide written informed consent;
- Body weight ranging from 50 to 100 kilograms (kg) \[110 to 220 pounds\] and body mass index (BMI) of 18 to 30 (kg/m2);
- Males and females aged 18 to 50 years;
- Willing to eat the food supplied during the study;
- Willing to refrain from strenuous exercise through the end-of-study visit. Subjects did not begin a new exercise program nor participate in any unusually strenuous physical exertion;
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and safety 12-lead ECG;
- Females of childbearing potential must use an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must be postmenopausal for ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).
Exclusion
- Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating;
- Current or recent (within 5 years) history of drug or alcohol abuse;
- History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion;
- Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study;
- Known allergy to hydrocodone, opioids, psychotropic or hypnotic drugs, moxifloxacin, or any member of the quinolone class drugs;
- Any history of frequent nausea or emesis regardless of etiology;
- Any history of seizures or head trauma with sequelae;
- Participation in a clinical drug study during the 30 days preceding the initial dose of study drug in this study;
- Use of any medication including thyroid hormonal therapy (hormonal contraception and hormonal replacement therapy in the form of estrogen with or without progestin is allowed), vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose of study drug;
- Any significant illness during the 30 days preceding the initial dose of study drug in this study;
- Any personal or family history of prolonged QT interval or disorders of cardiac rhythm;
- Abnormal cardiac conditions including hypertension;
- Abnormal cardiac condition denoted by any of the following:
- QT data corrected for heart rate using the Fridericia formula (QTcF) interval \>450 milliseconds (msec)
- PR interval \>240 msec or QRS \>110 msec
- Evidence of second- or third-degree atrioventricular block
- Pathological Q-waves (defined as Q-wave \>40 msec or depth \>0.5 millivolts \[mV\])
- Evidence of ventricular pre-excitation, complete left bundle branch block (LBBB), right bundle branch block (RBBB), or incomplete RBBB
- With a resting heart rate (HR) outside the range of 40 to 90 beats per minute (bpm);
- Abnormalities on physical examination, vital signs, safety 12-lead ECG, or clinical laboratory values, unless those abnormalities are judged clinically insignificant by the investigator;
- Oxygen saturation \<94% as measured by pulse oximetry (SpO2);
- Refusal to abstain completely from caffeine or xanthine during confinement;
- Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration through the end-of-study visit;
- Blood or blood products donated within 30 days prior to initial study drug administration or any time through the end-of-study visit, except as required by the study protocol;
- History of smoking or use of nicotine products within 45 days of initial study drug administration or a positive urine cotinine test;
- Positive results of urine drug screen or alcohol screen;
- Positive results of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV);
- Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities;
- The investigator believes the subject to be unsuitable for reason(s) not specifically stated in the exclusion criteria.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT02243241
Start Date
November 1 2012
End Date
May 1 2013
Last Update
September 17 2014
Active Locations (1)
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1
PPD Phase I Clinic
Austin, Texas, United States, 78744